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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019865
Company: LEGACY PHARMA

Products on NDA 019865

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAPACE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	AB	Yes	No
BETAPACE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	AB	Yes	Yes
BETAPACE	SOTALOL HYDROCHLORIDE	240MG	TABLET;ORAL	Prescription	AB	Yes	No
BETAPACE	SOTALOL HYDROCHLORIDE	320MG	TABLET;ORAL	Discontinued	None	No	No
BETAPACE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019865

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/30/1992	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/15/2023	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019865Orig1s026Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019865Orig1s026Corrected_ltr.pdf
06/03/2021	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019865s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019865Orig1s022ltr.pdf
05/10/2016	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019865s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019865Orig1s021ltr.pdf
08/17/2011	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019865s020ltr.pdf
02/03/2011	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019865s019ltr.pdf
07/26/2001	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
11/22/2000	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/2000	SUPPL-11	Labeling		Label is not available on this site.
10/01/2001	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865s10_Betapace.cfm
04/09/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/23/1999	SUPPL-8	Labeling		Label is not available on this site.
12/04/1995	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/26/1995	SUPPL-5	Labeling		Label is not available on this site.
04/20/1994	SUPPL-4	Labeling		Label is not available on this site.
09/06/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/20/1994	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/13/1993	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 019865

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/15/2023	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019865Orig1s026Corrected_lbl.pdf
06/03/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019865s022lbl.pdf
05/10/2016	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019865s021lbl.pdf
08/17/2011	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s020lbl.pdf
02/03/2011	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019865s019lbl.pdf
10/01/2001	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-865S010_Betapace_prntlbl.pdf

Therapeutic Equivalents for NDA 019865

BETAPACE

TABLET;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAPACE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	Yes	AB	019865	LEGACY PHARMA
BETAPACE AF	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	Yes	AB	021151	LEGACY PHARMA
SORINE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	075500	AIPING PHARM INC
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	076140	APOTEX
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	076214	APOTEX
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	077616	AUROBINDO PHARMA USA
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	207428	BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	207429	BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	077070	EPIC PHARMA LLC
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	075563	OXFORD PHARMS
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	075429	TEVA

TABLET;ORAL; 160MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAPACE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	Yes	AB	019865	LEGACY PHARMA
BETAPACE AF	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	Yes	AB	021151	LEGACY PHARMA
SORINE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	075500	AIPING PHARM INC
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	076140	APOTEX
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	076214	APOTEX
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	077616	AUROBINDO PHARMA USA
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	207428	BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	207429	BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	077070	EPIC PHARMA LLC
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	075563	OXFORD PHARMS
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET;ORAL	Prescription	No	AB	075429	TEVA

TABLET;ORAL; 240MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAPACE	SOTALOL HYDROCHLORIDE	240MG	TABLET;ORAL	Prescription	Yes	AB	019865	LEGACY PHARMA
SORINE	SOTALOL HYDROCHLORIDE	240MG	TABLET;ORAL	Prescription	No	AB	075500	AIPING PHARM INC
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	240MG	TABLET;ORAL	Prescription	No	AB	076140	APOTEX
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	240MG	TABLET;ORAL	Prescription	No	AB	075563	OXFORD PHARMS
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	240MG	TABLET;ORAL	Prescription	No	AB	075429	TEVA

TABLET;ORAL; 120MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAPACE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	Yes	AB	019865	LEGACY PHARMA
BETAPACE AF	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	Yes	AB	021151	LEGACY PHARMA
SORINE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	075500	AIPING PHARM INC
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	076140	APOTEX
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	076214	APOTEX
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	077616	AUROBINDO PHARMA USA
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	207428	BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	207429	BEXIMCO PHARMS USA
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	077070	EPIC PHARMA LLC
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	075563	OXFORD PHARMS
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET;ORAL	Prescription	No	AB	075429	TEVA

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